acukub@r.postjobfree.com

650-***-****

Jocel Morales

Education

University of Phoenix MBA (Global Management) 3.50 GPA

San Francisco State University Bachelor’s Degree (Health Science)

Kriger Research Group (CRO) CRA Certification

SMC Office of Education Certification (Insurance Billing & Coding)

Professional Experience

Aug’ 2014 – Current Bayer Pharmaceutical Berkeley, Ca.

Data Collections & Documents Analyst (Contractor)

Member of the FDA Observation Team to work on a special project. Working to implement an approved validation plan for compliance. Responsible for the review, audit, enter/change data & verifies corrections & reconciliation for analysis. Files and organized MBR’s/Clinical data files for queries and verification through SAP, MES, & LIMS.

Adept in working in a GCP/GMP regulated environment. Provide support for regulatory inspection and audit of companywide system.

Dec’ 2014- Jan’ 2015 Transition Therapeutic Inc. San Mateo, Ca.

Quality Assurance Consultant (Contractor)

Liaison with the internal & regional teams to ensure completeness & quality of documents.

Responsible for batch records/ Trial Master File (TMF) review for sponsor & CRO studies. Prepare, scan, process

& track electronic/paper documents per project guidelines. Evaluates/approves document change request (DCR’s) through compliance to meet cGMP. Assist in periodic audits of TMF’s & clinical documents. Works directly with medical monitor & QA managers for study protocol & study procedures.

Sept’ 2008 – March 2012 Arcadia Health Care S. F. Ca

Health Care Associate

Duties include assessments and coordination of patient care, administrative -scheduling appointments, and medical records management, patient education, med/care monitoring, and appropriate counseling.

Collect and record vital signs, Conduct drug accountability and regulated storage according to protocol.

Fall’ 2007 Kriger Research Group International (CRO)

Clinical Research Associate (Intern)

Project: To determine efficacy and optimal dose of (confidential compound)

Responsibilities: Managed assigned clinical study and performed quality reviews of CRF including IRB related documents. Verified case report form information against source documents and reconciled data entry queries. Ensured informed consent was administered properly and advised site of any execution issues. Performed drug accountability and reconciled counts with CRF, source data and dispensing logs. Oversaw and evaluated subject enrollment, and compiled and reviewed patients’ status tracking information. Developed and implemented site initiation, routine monitoring and closure checklists.

Dec’ 2009 to Jan’ 2010 Clinops S. F. Ca.

Clinical Data Specialist (Contractor)

Create and maintain Clinical Databases for multiple projects. Accountable for data management entry, review of

study invoices for reconciliation. Assisted in inspection preparation including data processing, deviation management, & internal audit. Coordinates scheduling and logistics for inspection related activities. Collaborates with other functional areas for activities related to prepare for inspection. Knowledge System Regulations (ISO 9001, CFR 820).

Dec’ 2007 – 2010 Business Manager / Project Coordinator:

Developed a business plan and helped implement to establish a water purification station business overseas.

Evaluate and finalize project budget(s).In addition, I’m the proprietor and the property manager of several rental properties in the bay area including a four unit dwellings abroad. Member of At-Home Consulting

Group in the peninsula region.

Jan’ 2007 – March 2007 Celera Diagnostics (through Pro-Unlimited) Alameda, Ca

Sr. Quality Compliance Inspector: Reviews and inspect raw materials, in-process and testing records for

production release. Finalized Manufacturing and QC documents (Device History Records) for completeness,

accuracy and compliance with FDA Regulations (QSR), ISO, and medical device related regulations. Provides

training on good documentation practice and record compliance to QA and QC, and Manufacturing. Reports non-conforming product (NCP’s) and processes in accordance with the quality procedure. Lead and assist team members in investigations and implements CAPA’s to the responsible areas. Perform visual and dimensional inspection of

non-chemical, raw material components in accordance with current raw material specifications. Collaborate with external department to ensure the timely inspection and release of raw material lots for use in GMP manufacturing. Perform data entry and scan documents into system database. Support Quality Investigations and provide written evaluation as needed. Coordinate incoming work schedule and provide status updates and required follow-up to ensure timely completion of investigations and documentation. Review protocol compliance, focusing on inclusion/exclusion requirements.

June’ 2004 – Sept’ 2004 Anosys (Stanford Affiliate), Menlo Park, Ca

Manufacturing Associate: Responsible for reviewing and revising SOP’s and log sheets binders and to make regulatory changes to the Master Batch Record (MBR’s) throughout manufacturing. Reviewed manufacturing documents for completeness, accuracy and compliance with GLP and FDA Quality System Regulations (QSR). Coordinate periodic follow-ups to track the progress and closure of corrective actions. Utilized the knowledge of cGMP/GCP to execute all activities for the processing of for clinical products. Performs environmental monitoring, records and replaces chart traces and assign personnel for sanitization of the facility as necessary. Collaborated with managers, supervisor and QA/QC for operational management and process improvement. Ensures all equipments

are properly maintained and calibrated. Orders raw materials as needed to ensure levels of inventories are up to date. Monitored and supports MFG in the development and testing of pre-clinical product through phase I/II studies of Oncology therapeutics.

Nov’ 1999 – Nov’ 2003 Genentech, South San Francisco, Ca

Bio-process Associate: Performs & complete all protein purification tasks via column chromatography (HPLC)

and purification skids. Troubleshoot equipment and process issues per SOP’s. Supports in the execution of

validation protocols for operations equipment and control systems. Accurately record and finished process documentation. Assisted to resolve technical, operational, and documentation discrepancies. Reviews/maintained batch master files, deviation reports and chromatogram for the slightest detail to support lot release of commercial bulk and clinical trial products. Working knowledge in the FDA regulations to safety requirements, risk assessments, cGMP/GCP, and manufacturing documentation. Efficient in following protocols and SOP’s. Other duties include

the following; responsible for setting up equipment, preparing buffers for process operation. In charged of training and qualifying new technician. Proficient in following all purification technique from extraction of the cells through final recovery in a cGMP/GCP environment. Involved in the entire purification steps for clinical and marketed drugs. Works independently on side projects to address process modification. A noted first aide coordinator for my shift

and a skid owner for the Enbrel campaign in 2003.

Relevant Skills

My academic background has provided me with the specialized skills needed to lead multinational work forces. My graduate curriculum is structured to provide the importance of a rigorous approach in a team environment and

diverse workforce.

Summary of qualifications

Communication skills: Bilingual. Excellent in oral and written communication. Able to write a clear/ concise

reports and observations Able to formulate a business and strategic plan for organizational improvements.

Computer skills: Proficient in Windows and Mac OS.

Project Management Skills: Able to coordinate and delegates task efficiently to set priorities in order to meet

established goals and required schedules. Track and report quality metrics for analysis to improve system

procedures. Provide status updates and required follow-up to ensure timely completion of goals and objectives.

Ability to simultaneously manage task associated with multiple

projects.

Strongest attributes: My reliability and depth character are my strong attributes. I work well with others and will

to adapt to changing work conditions with minimal supervision. I’m competent and diplomatic. My unceasing

optimism, self-motivation has allowed me to achieved academic and personal goals.

Volunteer experience

-Project Open Hand; Prepared and delivered meals to people infected with HIV.

-Young Life; counselor and mentored at risk youth.

Awards & Certificates

-Certified in most protein purification steps at Genentech

-Received an outstanding achievement award at Lassen College

-Awarded a recognition for most reliable employee of Arcadia Health Care

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